Technical Transfer of DST-F to CMO

Direct Award for the technical transfer from the pilot scale Supplier Lionex to the appointed Contract Manufacturing Organisation (CMO) under both Schedule 5, Condition 5 (a) and (b) and Condition 6 (a) and (b) of The Procurement Act 2023.

5 The following conditions are met in relation to the public contract—

(a) due to a particular supplier having intellectual property rights or other exclusive rights, only that supplier can supply the goods, services or works required, and

(b)there are no reasonable alternatives to those goods, services or works.

6 The following conditions are met in relation to the public contract—

(a)due to an absence of competition for technical reasons, only a particular supplier can supply the goods, services or works required, and

(b)there are no reasonable alternatives to those goods, services or works.

The explanations as to why the justification applies are as follows:

The Supplier has Intellectual Property Rights – Condition 5(a) APHA has an exclusive licence with Lionex for the current technology (IPR) for Diva Skin Test – Fusion (DST-F) production.

Absence of competition for technical reasons: Lionex have developed the DST‑F in partnership with APHA as the designated Pilot Scale provider. As a result, they hold the specialist knowledge, proprietary processes, and technical understanding required for its production and further development. No other supplier has been involved in the creation or pilot‑scale manufacture of DST‑F, and therefore no alternative provider has the capability or access to the necessary proprietary information to undertake the Technical Transfer to the CMO. For these reasons, Lionex are the only supplier in the market able to carry out the required work, demonstrating a clear absence of competition for technical reasons.

No reasonable alternatives: For the reasons outlined above, there are no reasonable alternatives in the market capable of delivering the Technical Transfer. No other supplier can complete the transfer to the newly appointed CMO, as they do not have the necessary knowledge, IPR or involvement in the development of DST‑F. Any alternative supplier would be required to redevelop a skin‑testing agent in collaboration with APHA, which would involve substantial time, resource investment, and a retendering of the CMO contract. This work cannot be delivered in‑house, as it requires specialist expertise that APHA does not have the capacity to provide.

Pre market engagement has not been carried out for this Technical Transfer requirement, as there is no other supplier in the market place who can deliver this service given the nature of the required services, however a UK05 & UK06 have been published, and the eight (8) day standstill period has been observed, to inform the market of this direct award without competition.